NCT01421121

Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.

Conditions

• Infection, Viral, Enterovirus

Interventions

Type	Name	Description
BIOLOGICAL	100U EV71 vaccine with adjuvant	inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval
BIOLOGICAL	200 U EV71 vaccine with adjuvant	inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval
BIOLOGICAL	400U EV71 vaccine with adjuvant	inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
BIOLOGICAL	200U EV71 vaccine without adjuvant	inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval
BIOLOGICAL	Placebo	0.5ml placebo, two doses, 28 days interval

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2011-08-22
• Last updated: 2012-11-27

Locations

1 site across 1 country: China